mNGS for Detection of Pathogens for Pulmonary Infection | NCT03798925

Studies
mNGS for Detection of Pathogens for Pulmonary Infection

NCT03798925

Sponsor

Sir Run Run Shaw Hospital

Status

Unknown status

Last Update Posted

Jan 10, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pulmonary Infection

Interventions

None Intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 19, 2018Actual

Primary Completion Date

Feb 2019Estimated

Completion Date

Feb 2019Estimated

First Submitted Date

Dec 29, 2018

First Submission Date that Met QC Criteria

Jan 7, 2019

First Posted Date

Jan 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2019

Last Update Posted Date

Jan 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jian-cang Zhou M.D., Department of Infectious Diseases, Sir Run Run Shaw HospitalPrincipal Investigator

Lead Sponsor

Sir Run Run Shaw HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
None Intervention	Other	It is observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microbiological diagnosis (pathogen of pulmonary infection)	the final microbiological diagnosis (pathogen of pulmonary infection) after using of every detection method and combined with clinical manifestations.	through study completion, up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pulmonary infection as the primary diagnosis
Bronchoalveolar lavage fluid can be obtained

Exclusion Criteria:

when the primary diagnosis is tumor or connective tissue diseases
microbiological diagnosis is confirmed before bronchoalveolar lavage
not enough bronchoalveolar lavage fluid for mNGS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sir Run Run Shaw Hospital	Recruiting	Hangzhou	Zhejiang	310016	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided